MAUDE Adverse Event Report: ETHICON INC. MONOCRYL SUTURE 36"(90CM) 3-0 VIO; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	Y527H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
Event or Problem Description
It was reported a patient underwent an unknown surgery on (b)(6) 2018 and suture was used.The suture was detached from the needle during use.Further details are not provided.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 09/25/2018 evaluation: an empty opened foil, a labeled winding former with a parked needle/suture, a parked detached needle, and unopened samples were returned for analysis.During the visual inspection of detached needle, the swage and attachment area were as expected.The barrel hole of the needle was examined under magnification and no suture remnant was noted.The suture was examined and the insertion end was measured, but did not meet the requirement.In addition, a functional test was performed on the other end and the pull force met the requirements.Unopened samples were examined, and no defects were found on the packages.The samples were opened, and the swage and attachment area were as expected.However, the second representative sample presented a detached needle of an end.The suture was examined, and the insertion end was measured and did not meet the requirement.No defects or needle pull were noted for the other sample.A functional test was performed on an end and the double armed and the pull force met the requirements.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.Per condition of the opened sample received the assignable cause of pull off suture needle is a short insertion.Per the condition of a representative sample received, pull off suture needle was found on the sample.

• Brand Name: MONOCRYL SUTURE 36"(90CM) 3-0 VIO
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7804847
• Report Number: 2210968-2018-75319
• Device Sequence Number: 1116671
• Product Code: GAN
• UDI-Device Identifier: 10705031059450
• UDI-Public: 10705031059450
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K960653
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: Y527H
• Device Lot Number: LGM259
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2018
• Initial Date Received by Manufacturer: 07/26/2018
• Supplement Date Received by Manufacturer: 08/31/2018
• Initial Report FDA Received Date: 08/22/2018
• Supplement Report FDA Received Date: 09/25/2018
• Patient Sequence Number: 1